Mon.Aug 31, 2020

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Vir, GSK push coronavirus antibody drug straight into mid-stage tests

Bio Pharma Dive

The two companies, chasing rival treatments from Eli Lilly, Regeneron and more, aim to produce their first study results by the end of the year.

Antibody 277
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AstraZeneca Expands Phase III COVID-19 Vaccine Trial into the U.S.

BioSpace

The U.S. expansion will recruit up to 30,000 adults over the age of 18 years from a broad range of racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions.

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Nestlé buys the rest of Aimmune, aiming to boost a struggling peanut allergy treatment

Bio Pharma Dive

The Swiss firm will take over the launch of Aimmune's Palforzia, sales of which have disappointed since its approval in January.

Allergies 277
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Lumen Nabs $16 Million in Series B to Support Clinical Programs

BioSpace

Lumen Biosciences closed a $16 million Series B funding round that will support the development of its three clinical programs aimed at C. difficile, norovirus and traveler’s diarrhea.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Top 10 myths about working with the FDA for an oncology drug approval

Bio Pharma Dive

Debunking myths around working with the FDA for oncology drug approval.

Drugs 300
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Preliminary Study Results Indicate COVID-19 Might be Able to Travel on Food

XTalks

A new study exploring the potential that COVID-19 can linger on food, including frozen seafood, draws connections between recent outbreaks of the virus in China, Vietnam and New Zealand. The study, “ Seeding of outbreaks of COVID-19 by contaminated fresh and frozen food ,” was published in the journal BioRxiv which circulates preliminary findings that have not been scrutinized by peer review.

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Study: Portable, point-of-care COVID-19 test could bypass the lab

Scienmag

Credit: Photo courtesy of Bill King, University of Illinois CHAMPAIGN, Ill. — As COVID-19 continues to spread, bottlenecks in supplies and laboratory personnel have led to long waiting times for results in some areas. In a new study, University of Illinois, Urbana-Champaign researchers have demonstrated a prototype of a rapid COVID-19 molecular test and a […].

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Community Outbreak Investigation of SARS-CoV-2 Transmission Among Bus Riders in Eastern China

JAMA Internal Medicine

This cohort study examines the potential for airborne spread of COVID-19 through investigation of an outbreak among bus riders in Eastern China.

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Brain protein linked to seizures, abnormal social behaviors

Scienmag

UC Riverside mouse study focused on neurons in the hippocampus Credit: Ethell lab, UC Riverside. A team led by a biomedical scientist at the University of California, Riverside has found a new mechanism responsible for the abnormal development of neuronal connections in the mouse brain that leads to seizures and abnormal social behaviors. The researchers […].

Protein 97
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IL-6 Inhibitor Kevzara Flops in Second Phase III COVID-19 Study

BioSpace

Another Kevzara study in hospitalized COVID-19 patients failed to meet primary and secondary endpoints.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Investigating host tolerance to genes that jump

Scienmag

University of Houston evolutionary geneticist awarded $1.8 million grant Credit: University of Houston Believe it or not, your genes are 50% parasite, and opportunistic at that. They tend to jump onto sperm and egg cells to replicate in the next generation, a process that can devastate an egg or sperm cell. A University of Houston […].

Gene 97
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Boston Pharmaceuticals Licenses Potential NASH Treatment from Novartis

BioSpace

Boston Pharmaceuticals licensed the drug candidate BOS-580, an injectable, genetically engineered variant of human FGF21.

Licensing 126
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Nerve cells with energy saving program

Scienmag

Thanks to a metabolic adjustment, the cells can remain functional despite damage to the mitochondria Credit: MPI f. Biology of Ageing/ E. Motori Mitochondria are the power plants of our cells and play an important role in providing energy for normal function of the tissues in our body. Nerve cells are particularly dependent on mitochondria […].

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Takeda sets up deal to distribute Moderna’s COVID-19 vaccine in Japan

BioPharma Reporter

Takeda positions itself to distribute 40 million doses of Modernaâs COVID-19 vaccine in Japan starting next year.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Data Shows Promise for Early Rhythm Control Therapy in Atrial Fibrillation Patients

BioSpace

According to new data from the EAST-AFNET 4 trial that was released on Aug. 29, patients with atrial fibrillation appear to benefit from early rhythm control therapy.

Trials 98
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Your paper notebook could become your next tablet

Scienmag

Credit: Purdue University/Ramses Martinez WEST LAFAYETTE, Ind. – Innovators from Purdue University hope their new technology can help transform paper sheets from a notebook into a music player interface and make food packaging interactive. Purdue engineers developed a simple printing process that renders any paper or cardboard packaging into a keyboard, keypad or other easy-to-use […].

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How COVID-19 is Changing FDA Approval and Clearance Processes

BioSpace

The COVID-19 pandemic is changing the FDA irrevocably, resulting in a more dynamic, streamlined FDA that is more willing to embrace digital technology, according to panelists at the recent OC LIFe (Lifesciences Innovators Forum) virtual presentation, “COVID-19: Changes In FDA Approval & Clearance.

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Front-line physicians offer COVID-19 insights

Outsourcing Pharma

A recent study from healthcare insights company Sermo shares information and perspectives that trial and pharma professionals could learn from.

Trials 92
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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Scientists Enhance Exercise Endurance by Blocking a Key Fat-Regulating Enzyme

BioSpace

In a groundbreaking new study, scientists at Harvard University have identified one enzyme that seems to dictate the limits of our physical performance.

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Hindawi Limited announces open access partnership with SAGE Publishing

Scienmag

Three of SAGE Publishing’s open access journals will publish with Hindawi under a new collaborative publishing agreement Credit: © Hindawi Limited logo © SAGE Publishing logo SAGE and Hindawi have recently entered into a publishing partnership agreement whereby the latter will publish and develop three SAGE gold open access journals for a period of at […].

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COVID-19 cell therapy drives Mesoblast to seek manufacturing muscle

BioPharma Reporter

Mesoblast plans ârapid scale-up in manufacturingâ to meet anticipated demand for COVID-19 cell therapy.

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People with less body response to stress task had more PTSD signs after COVID-19 began

Scienmag

Study findings surprised researchers, who had expected the reverse, Baylor University researcher says Credit: Baylor University People who did not have a large heart rate response to a stress task surprised researchers later — after the onset of the COVID-19 pandemic — when they showed more symptoms of post-traumatic stress disorder related to the crisis […].

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Biorad HRLC System Interface Modell 822

BioTech 365

EUR 250,00Angebotsende: Montag Sep-28-2020 14:43:44 CESTSofort-Kaufen für nur: EUR 250,00Sofort-Kaufen | Zur Liste der beobachteten Artikel hinzufügen Biotech365 : Biorad HRLC System Interface Modell 822 BioMarketplace You want to propose your products or a Biotech Company, a Biotech Tool or … Continue reading →

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Radiocarbon dating and CT scans reveal Bronze Age tradition of keeping human remains

Scienmag

Credit: Wiltshire Museum, copyright University of Birmingham/David Bukachit Using radiocarbon dating and CT scanning to study ancient bones, researchers have uncovered for the first time a Bronze Age tradition of retaining and curating human remains as relics over several generations. While the findings, led by the University of Bristol and published in the journal Antiquity, […].

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Gilead and Jounce Ink Potential $805 Million Immuno-Oncology Pact

BioSpace

Gilead Sciences and Jounce Therapeutics entered a discovery and development deal to exclusively license Jounce’s JTX-1811 immuno-oncology program.

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CU Anschutz researchers shed light on split-second decision making

Scienmag

Study shows cerebellum is key to ‘go-no go’ decision process AURORA, Colo. (Aug. 31, 2020) – A little understood region of the cerebellum plays a critical role in making split-second `go-no go’ decisions, according to a new study from researchers at the University of Colorado Anschutz Medical Campus. “We wanted to know how this kind […].

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Church’s Chicken Competes with Other Established Fried Chicken Brands

XTalks

Texas-inspired Atlanta-based chicken joint, Church’s Chicken, has introduced a new “Go Box” that allows for on-the-go meals everywhere. The company was built on the idea of convenience and accessibility for quality and value. Now Church’s Chicken is shifting their goal to accommodate the consumer habits that have changed due to the novel coronavirus.

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Study provides insight on how to build a better flu vaccine

Scienmag

New approach enables scientists to see how immune system responds to vaccination Flu season comes around like clockwork every year, and sooner or later everyone gets infected. The annual flu shot is a key part of public health efforts to control the flu, but the vaccine’s effectiveness is notoriously poor, falling somewhere from 40% to […].

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Relocating Internationally to Further Your Career – A Neuroscientist’s Perspective

BioSpace

Are you willing to relocate internationally to further your career? It can be a difficult decision with much to consider including language, cultural and industry differences.

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Trial supports first specific treatment for obstructive hypertrophic cardiomyopathy

Scienmag

EXPLORER-HCM trial presented in a Hot Line Session today at ESC Congress 2020 Sophia Antipolis, France – 29 Aug 2020: Mavacamten improves heart function and symptoms in patients with obstructive hypertrophic cardiomyopathy, according to results of the EXPLORER-HCM trial presented in a Hot Line session today at ESC Congress 2020.1 “The results of this pivotal […].

Trials 72
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.